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The Effects of CGMP in Children and Adults With PKU

NCT04076176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-20

No results posted yet for this study

Summary

Randomised controlled trial with a crossover design. For early and continuously treated patients with phenylketonuria (PKU) that are adherent. Two 12-week periods where patients consume either casein glycomacropeptide (CGMP) based protein substitute or a free amino acid (AA) based protein substitute. 4 week wash out period in between. The protein substitutes will be consumed daily together with the patient's regular low protein diet.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

CGMP protein substitute

PKU sphere is a powdered, low phenylalanine protein substitute, containing a balanced mix of casein glycomacropeptide (CGMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals, trace elements and the omega-3 long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid.

DIETARY_SUPPLEMENT

L-amino acid protein substitute

Patient may choose from a list of products, specified in the protocol, that are nutritionally comparable to PKU Sphere.

Sponsors & Collaborators

  • Arla Foods

    collaborator INDUSTRY

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Denmark
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076176 on ClinicalTrials.gov